HIV Indicator Diseases in Hospital and Primary Care

HIV Infections Clinical Trial

— #AwareHIV  

Official title:

Supporting Health Care Professionals in Hospital and Primary Care to Promote Adequate HIV Risk and Indicator Condition Driven Testing in Routine Care.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05225493
• Other study ID #: MEC-2021-0277
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: May 2024

Study information

• Verified date: January 2022
• Source: Erasmus Medical Center
• Contact: Casper Rokx, MD PhD
• Phone: +31681336328
• Email: c.rokx[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients are frequently evaluated by physicians for medical work-up of HIV indicator conditions in hospital and in primary care at the general practitioner. Testing for HIV is indicated with HIV indicator disorder but often omitted in clinical work-up. Besides the fact that HIV testing is forgotten, there are other reasons such as an underestimation of the risk of HIV in the event of indicator disorders, stigma and difficulties in discussing the test with a patient. Also and more relevant for primary care than for the hospital, practical challenges can exist for a patient to go to a laboratory, or costs are a hurdle.

This project focuses on improving HIV indicator condition driven testing in different settings of the HIV epidemic, initially in the Netherlands as low HIV prevalence setting followed by an assessment of its benefit in different international settings. A specific focus will also be on the Rotterdam area in the Netherlands which has a high prevalence of undiagnosed HIV in the Netherlands. The ultimate aim is to decrease the number of undiagnosed HIV in populations, improve the 90-90-90 HIV cascade of care goals particularly its first pillar, and to help supporting the UNAIDS goal to end HIV/AIDS

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of an HIV indicator conditions.

Exclusion Criteria:

• Below 18 years of age

• Recent HIV test (< 12 months, except for mononucleosis-like disease and STDs)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Candida Infection
• Candidiasis
• Cervical Intraepithelial Neoplasia
• Communicable Diseases
• Dermatitis
• Dermatitis, Seborrheic
• Diarrhea
• Diarrhea Chronic
• Disease
• Herpes Zoster
• HIV Infections
• Immunologic Deficiency Syndromes
• Infections
• Infectious Mononucleosis
• Leukopenia
• Lymphadenopathy
• Pneumonia
• Primary Health Care
• Psoriasis
• Sexually Transmitted Diseases
• Sexually Transmitted Diseases, Viral
• Thrombocytopenia
• Uterine Cervical Dysplasia
• Virus Diseases
• Weight Loss

Intervention

Behavioral:
• Peer to peer feedback
HIV experts contact non-HIV specialised treating physicians on individual patient care to recommend HIV testing

Diagnostic Test:
• HIV rapid test
Free HIV rapid tests are provided to non-HIV specialised treating physicians to use in individual patient care in patients at risk of HIV

Locations

Country	Name	City	State
Netherlands	Carlijn CCE Jordans	Rotterdam	South-Holland

Sponsors (12)

Lead Sponsor	Collaborator
Erasmus Medical Center	AwareHIV Project Group, Huisartsen Groep Rotterdam, Huisartspraktijk Capelle ad IJssel, Huisartspraktijk Gezondheidscentrum Mathenesserlaan, Huisartspraktijk Handellaan, Huisartspraktijk Leerdam, Leiden University Medical Center, Maasstadziekenhuis, Medical Center Haaglanden, Rijnstate Hospital, TU Delft department of Artificial Intelligence and MyTomorrows

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The number of HIV tests in relation to the total number of HIV tests done by gender, ethnical background, age, previous HIV test and HIV indicator conditions of the patient, primary care setting and hospital setting.		3 year
Other	Center for Disease Control and Prevention (CDC) HIV classification of the patients with an HIV positive test.		3 year
Primary	The number of adequately performed HIV tests of identified HIV indicator conditions in relation to the total number of identified HIV indicator conditions by physicians in hospital settings during the project.		3 year
Primary	The number of adequately performed HIV tests of identified HIV indicator conditions in relation to the total number of identified HIV indicator conditions by general practitioners in primary care during the project.		3 year
Secondary	The number of positive HIV tests in relation to the total number of HIV tests for identified HIV indicator conditions.		3 year
Secondary	The percentage of adequately HIV tested patients per HIV indicator condition and per medical specialism.		31 year
Secondary	The prevalence of HIV indicator conditions in primary care and hospitals.		3 year
Secondary	The incidence of HIV indicator conditions in primary care and hospitals.		3 year
Secondary	A sensitive and specific supervised artificial Intelligence tool that recognizes risk factors for HIV and HIV indicator conditions through natural language processing (NLP) and supports the hospital and primary care in proactive HIV testing policies.		3 year
Secondary	Acceptance of HIV testing in by patients, medical specialist and in primary care.	Assessed by questionnaire	3 year
Secondary	The costs of pro-active HIV indicator case finding and relation to the savings and QALY's gained	Costs of the program in relation to the savings in costs and QALY's lost as a consequence of earlier HIV diagnosis with subsequent prevented HIV transmission, AIDS comorbidity and hospital admissions.	3 year